Extra Strength Balm

Manufacturer
NATURES FORMULAE HEALTH PRODUCTS LTD.
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:36:45

Label at a glance#

ProductExtra Strength Balm
Active ingredientCAPSICUM, MENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Provides warming pain relief.

Dosage and administration

Apply a thin layer to affected area not more than 3-4 times daily, massaging well into skin. Wash hands well after use. Patch test recommended prior to use. Spatula recommended to reduce contact with the product. Do not inhale directly–keep lid on product when not in use.

Storage and handling

Store in a cool, dry place.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsicum (from Capsicum Frutescens fruit extract) 5%

Menthol 2.5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic (Counterirritant)

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Provides warming pain relief.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with the eyes

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use • while pregnant or breastfeeding.

OTC - DO NOT USE SECTION

Do not apply to • wounds • damaged skin • bandage tightly • with external heat. This may result in skin irritation or skin burn.

OTC - STOP USE SECTION

Stop use and ask a doctor if • condition worsens, • if symptoms persist for more than 7 days • clear up and reoccur within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer to affected area not more than 3-4 times daily, massaging well into skin. Wash hands well after use. Patch test recommended prior to use. Spatula recommended to reduce contact with the product. Do not inhale directly–keep lid on product when not in use.

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, butyrospermum parkii (shea) butter, calendula officinalis flower extract, capryloyl glycerin, cinnamomum zeylanicum (cinnamon) leaf oil, cocos nucifera (coconut) oil, diheptyl succinate, elettaria cardamomum (cardamom) seed oil, eugenia caryophyllus (clove) bud oil, glycine soja (soybean) oil, olea europaea (olive) fruit oil, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) extract, rosmarinus officinalis (rosemary) leaf oil, rubus idaeus (raspberry) seed oil, sebacic acid copolymer, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopherol, zingiber officinale (ginger) root oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11Saje

Natural Wellness

Extra Strength Balm

Warming pain relief ointment

net wt 25 g | 0.9 fl oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2735141capsicum extract 5 % / menthol 2.5 % Topical OintmentPSN1
2735141Capsicum extract 0.05 MG/MG / menthol 0.025 MG/MG Topical OintmentSCD1
2735141capsicum extract 5 % / menthol 2.5 % Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAPSICUM Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-030-01Extra Strength Balm1 in 1 CARTONOINTMENT11
69204-030-01Extra Strength Balm25 g in 1 JAROINTMENT251

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69204-03069204-030-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength BalmCAPSICUM, MENTHOLNATURES FORMULAE HEALTH PRODUCTS LTD.498a5e2a-4de0-561c-e063-6394a90ac05c2026-01-29WarningsExact identifier
ndc (package): 69204-030-01
ndc (product): 69204-030
ndc11 (package): 69204003001
spl id: 498a5e2a-4de1-561c-e063-6394a90ac05c
spl set id: 498a5e2a-4de0-561c-e063-6394a90ac05c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.